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Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Primary Purpose

Allergic Bronchopulmonary Aspergillosis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PUR1900

Placebo

About this trial

This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis focused on measuring Aspergillosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Is a male or female, 18 to 75 years old (inclusive) at the time of signing the informed consent.
Has a body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
Has a historical diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update.
Has a confirmed historical diagnosis of ABPA, as per the Modified International Society for Human and Animal Mycology (ISHAM) working group 2013 criteria.
Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma)
Has a serum immunoglobulin (Ig) E ≥1000 IU/mL during screening (Visit 1 or Visit 2).
Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 ≥50% of predicted normal for age, sex, race, and height (Quanjer et al 2012) at a screening visit.
Has a documented stable asthma medication regimen during screening (Day 28 to Day 1), including SABA, LABA, and LTRA use and inhaled and/or oral GCS.
Subjects who are sexually active, male subjects able to father a child, and female subjects of childbearing potential must agree to follow the contraception requirements of this protocol.
Can demonstrate the correct inhalation technique for the use of the delivery device at screening and before dosing.

Exclusion Criteria:

Is a female of childbearing potential who is pregnant or lactating or who plans to become pregnant during the study. A woman is considered to be of childbearing potential unless she is either permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or postmenopausal (had no menses for 12 months without an alternative medical cause).
Has a history of life-threatening asthma within the last 5 years, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
Had an occurrence of asthma or ABPA exacerbations within the 28 days before screening or during the 28-day period before Day 1.
Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
Received any investigational medical product in a clinical research study within the previous 3 months before dosing in this study.
Has previously received PUR1900.
Has a history of any significant drug or alcohol abuse in the past 2 years before screening, as judged by the investigator.
Has current tobacco or inhaled marijuana use or history of smoking tobacco or marijuana within the last 6 months before screening.
Is a current user of e-cigarettes or has used these products within the last 6 months before screening.
Has a positive urine test result for drugs of abuse, alcohol, or cotinine at screening
Has a history of allergies to or hypersensitivity reactions after dosing of itraconazole or other antifungal azoles.
Had a major trauma or surgery within the last 28 days before screening.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mg PUR1900

20 mg PUR1900

35 mg PUR1900

Placebo

Arm Description

Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Placebo

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Incidence of intraday FEV1 declines

Respiratory rate

Blood pressure

Systolic pressure over diastolic pressure

Heart rate

Beats per minute

Oxygen saturation

As a percentage

Physical examination findings

Physician's notes

Clinical laboratory test results

Lab reports with any out of range results flagged

12-Lead electrocardiogram findings

ECG report and tracing

Secondary Outcome Measures

Sputum concentrations of itraconazole and hydroxy-itraconazole

Sputum eosinophils

To evaluate the effect of PUR1900 on pulmonary function following single- and multiple-dose administration of PUR1900

Asthma Control Questionnaire-6 (ACQ 6)

Scores range between 0 (totally controlled) and 6 (severely uncontrolled).

Change from baseline (Day 1) to Day 28 in A fumigatus burden in sputum

As assessed by quantitative PCR and sputum culture

Cmax (maximum observed concentration in plasma)

Tmax (time to maximum concentration in plasma)

AUC (area under the concentration-time curve)

CL/F (clearance)

Vz/F (apparent volume of distribution)

Full Information

NCT ID

NCT03960606

First Posted

May 14, 2019

Last Updated

August 25, 2021

Sponsor

Pulmatrix Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03960606

Brief Title

Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Asthmatic Patients With ABPA

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 Pandemic

Study Start Date

July 31, 2019 (Actual)

Primary Completion Date

July 14, 2020 (Actual)

Study Completion Date

July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulmatrix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Detailed Description

This is a randomized, double-blind, multicenter, placebo controlled, multiple-arm study. Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days. The doses of PUR1900 are stated in this protocol as the respective nominal doses of itraconazole. Subject eligibility for the study will be determined within 28 days before the first dose of study drug (Day 1) and will be confirmed between 9 and 6 days before dosing and again on Day 1. Eligible subjects will begin daily dosing with study drug (PUR1900 or placebo) on Day 1. Subjects will return to the study site for visits on Days 2, 7, 14, and 28 and will be dosed at the study site. The remaining daily doses of study drug will be self-administered at home. A follow-up visit will occur 7 to 10 days after the last dose of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Bronchopulmonary Aspergillosis

Keywords

Aspergillosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The study will be performed in a double-blind manner. All study drug will be supplied in identical packaging and will be similar in color, smell, taste, and appearance to enable double-blind conditions. All study personnel will remain blinded until after database lock, unless the nature of their activities in the study specifically requires them to be unblinded. Any study documents, supplies, and tools will be reviewed to identify components that have the potential to unblind the study, and blinding restrictions will be applied where appropriate.

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mg PUR1900

Arm Type

Experimental

Arm Description

Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Arm Title

20 mg PUR1900

Arm Type

Experimental

Arm Description

Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Arm Title

35 mg PUR1900

Arm Type

Experimental

Arm Description

Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Combination Product

Intervention Name(s)

PUR1900

Intervention Description

PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.

Intervention Type

Combination Product

Intervention Name(s)

Placebo

Intervention Description

PUR1900 placebo

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Time Frame